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Article CommentaryCommentary

A Risk-Based Approach for Managing Affinity Resin Contaminations

Beth Fulton and Angelica Welch
PDA Journal of Pharmaceutical Science and Technology September 2023, 77 (5) 420-435; DOI: https://doi.org/10.5731/pdajpst.2022.012814
Beth Fulton
ValSource Inc.
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  • For correspondence: bfulton@valsource.com
Angelica Welch
ValSource Inc.
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PDA Journal of Pharmaceutical Science and Technology: 77 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 77, Issue 5
September/October 2023
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A Risk-Based Approach for Managing Affinity Resin Contaminations
Beth Fulton, Angelica Welch
PDA Journal of Pharmaceutical Science and Technology Sep 2023, 77 (5) 420-435; DOI: 10.5731/pdajpst.2022.012814

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A Risk-Based Approach for Managing Affinity Resin Contaminations
Beth Fulton, Angelica Welch
PDA Journal of Pharmaceutical Science and Technology Sep 2023, 77 (5) 420-435; DOI: 10.5731/pdajpst.2022.012814
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More in this TOC Section

  • Challenges and Solutions to Manufacturing of Low-Viscosity, Ultra-High Concentration IgG1 Drug Products: From Late Downstream Process to Final Fill Finish Processing
  • Retrospective Evaluation of Cycled Resin in Viral Clearance Studies - A Multiple Company Collaboration - Post ICH Q5A(R2) Review
  • Addressing Medical Device Extractables and Leachables via Non-Target Analysis (NTA); The Analytical Evaluation Threshold (AET) and Quantitation
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Keywords

  • Affinity resin
  • Protein A
  • Risk-based impact assessment
  • RBIA
  • Contamination
  • Bioburden
  • Biofilm
  • Chromatography

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